Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome

NCT00543478 | Unknown Phase 4 DMC

• 2 other identifiers: SBURC 071006MED
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Probiotics are friendly bacteria normally present in food products like yogurt whereas irritable bowel syndrome is a longstanding functional disorder characterized by abdominal pain and altered bowel habits either diarrhea or constipation dominant without a definitive etiology. Study Hypothesis:Does probiotics(Saccharomyces boulardii improves daily bowel symptoms and quality of life in patients with diarrhea dominant irritable bowel syndrome?

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome; Diarrhea; Probiotics

Outcome Measures

Primary Outcomes (1)

• Any Improvement in symptoms of number of bowel habits, urgency, straining,sense of incomplete evacuation, stool form (evaluated by Bristol stool form scale, abdominal pain and bloating/flatulence

  10 weeks

Secondary Outcomes (1)

• Improvement in quality of life in diarrhea dominant IBS by validated IBS-QOL questionnaire.

  10 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Receive active drug Saccharomyces boulardii 250mg twice a day for 8 weeks.

Drug: Saccharomyces boulardii

2

PLACEBO COMPARATOR

Placebo will be given twice a day for 10 weeks

Drug: Methyl cellulose powder (low viscosity)

Interventions

Saccharomyces boulardii DRUG

250mg, twice a day in sachets, for 8 weeks

1

Methyl cellulose powder (low viscosity) DRUG

twice a day sachets for 10 weeks

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients will be recruited from gastroenterology clinic at Aga Khan University hospital with diagnosis of diarrhea dominant irritable syndrome.
• Age between 18- 60 years.
• Male and female both.
• Organic gastrointestinal diseases excluded by baseline laboratory and sigmoidoscopy/colonoscopy and biopsy within last 2 years.
• All Patients need to satisfy ROME III criteria

You may not qualify if:

• Age \< 18 and \> 60 years
• Pregnant and lactating females
• Patients on laxatives or antidiarrheal drugs that could influence the motility of gut
• Patient on antibiotics or within 2 weeks of starting protocol.
• Not willing to participate
• Non-compliant in run in period.
• Patients taking Husk.
• Diabetic patients

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Gastroenterology outpatients clinics,Aga Khan University hospital

Karachi, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lubna Kamani, FCPS,MRCP

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lubna Kamani, FCPS, MRCP

CONTACT

9221-4864659; lubna.kamani@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2007
• First Posted: October 15, 2007
• Study Start: October 1, 2007
• Study Completion: July 1, 2008
• Last Updated: October 15, 2007

Record last verified: 2007-10

Locations

PA (1)